Cirrhosis patients have significantly more fatigue than do matched controls from the general population, and this fatigue often persists 1 year after liver transplantation, reported Dr. Evangelos Kalaitzakis and colleagues in the February issue of Clinical Gastroenterology and Hepatology.

Moreover, the fatigue in cirrhosis patients is highly correlated with depression and anxiety, and it impairs quality of life, the authors wrote.

Dr. Kalaitzakis of the University of Gothenburg, Sweden, studied 108 cirrhosis patients seen at a single institution between May 2004 and April 2007. Mean age was 52 years, and 36 of the 108 were women.

At study entry, all patients completed the Fatigue Impact Scale (FIS), which assesses fatigue in the physical, psychosocial, and cognitive domains and gives a total fatigue score. Patients were compared with a random sample of the general Swedish population who were matched to cirrhosis patients.
Patients scoring more than two standard deviations above the general population cohort on the FIS were classified as fatigued. At baseline, cirrhosis patients scored significantly higher than controls on the total FIS score and on the physical, psychosocial, and cognitive domains (P less than .001 for all).
Participants also completed the Hospital Anxiety and Depression scale (HAD). Significant depression and anxiety on the HAD were both highly correlated with total fatigue as measured by the FIS (P less than .001).

Indeed, compared with controls, cirrhosis patients were more likely to have borderline or significant anxiety (12% vs. 21% and 8% vs. 16%, respectively, P = .034) and borderline or significant depression (9% vs. 23% and 6% vs. 14%, respectively, P = .001), the authors reported.
Clinical factors played a role as well, according to the analysis. In univariate analysis, higher Child-Pugh class was significantly correlated with overall fatigue, as were current ascites or history of ascites (P less than .001 for all).

Current overt hepatic encephalopathy also was significantly correlated with overall fatigue, although
somewhat less so than the other factors (P less than .05).

Factors not significantly related to total fatigue included liver disease etiology, existence of stable or bleeding varices, and malnutrition, the authors said.
In fact, in multivariate analysis, FIS scores were only related to depression, anxiety, Child-Pugh score, and low serum cortisol levels, they wrote.

Overall, 66 out of the 108 patients completed a liver transplant, and follow-up data were available at 1 year on 60 of these patients.
“FIS domain and total scores had improved 1 year post-transplant, but transplant recipients still had higher physical fatigue compared to controls,” Dr. Kalaitzakis and associates noted.

Of the 37 patients whose FIS scores before transplant had classified them as physically fatigued, 17 (46%) continued to be fatigued after transplant, wrote the authors.
Compared with the patients whose fatigue levels dropped post transplant, these 17 patients once again
were more likely to have significant or borderline depression at baseline, according to the HAD (15% vs.35% and 15% vs. 41%, respectively; P = .019).

“Psychological distress was found to be a major determinant of fatigue in cirrhosis,” the authors concluded.

Although some previous studies have found that antidepressants do not improve fatigue, at least in cancer patients, “our findings … indicate that patients with cirrhosis and significant anxiety or depression confirmed by a psychiatrist may benefit from specific treatment for these disorders, which could lead to improvement in fatigue,” they wrote. “However, this would need to be formally tested in interventional trials.”

Dr. Kalaitzakis and associates stated that they had no conflicts of interest to disclose and no grant support for this study. ■

Updated Mar 3, 2015Reducing the cost of new hepatitis C drugsDaclatasvir, Harvoni (ledipasvir/sofosbuvir)/Sovaldi/Viekira Pak.
An index of articles pointing the reader to the current controversy over the high price of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.Class Action Lawsuit Challenges the Exorbitant Pricing of Gilead's Hepatitis-C Drug Sovaldi - The situation has Medicaid plans and insurers nationwide groping for the right balance. Worldwide patients are unable to afford treatment, while others wait in the wings on coverage.

U.S. FDA Approves Gileads Harvoni (Ledipasvir/Sofosbuvir)
Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.

Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.Continue reading...

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Daclatasvir/VX-135..Vertex said it will license an experimental hepatitis C drug called VX-135 to Alios BioPharma..As a reminder (VX-135) is still on partial clinical hold by the FDA in the U.S. **Clinical Trials @ HCV Advocate-Vertex

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